PAXG Out in the Country

Last updated: February 8, 2021
Sponsor: IRCCS San Raffaele
Overall Status: Active - Recruiting

Phase

4

Condition

Adenocarcinoma

Pancreatic Cancer

Pancreatic Disorders

Treatment

N/A

Clinical Study ID

NCT04480268
PACT31
  • Ages 18-75
  • All Genders

Study Summary

The objective of this study is to assess the reproducibility of PAXG regimen as first-line/primary chemotherapy in daily clinical practice in Pancreatic Ductal Adenocarcinoma (PDAC) borderline resectable, locally advanced or metastatic patients out of a large volume center.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • cyto/histological diagnosis of pancreatic adenocarcinoma;
  • locally advanced and metastatic disease corresponding to clinical stage III-IVaccording to TNM 8th Ed. 2017 and borderline resectable disease as anatomicallydefined according to NCCN Guidelines Version 1.2020 - Pancreatic Adenocarcinoma andbiologically defined according to the International consensus on definition andcriteria of borderline resectable pancreatic ductal adenocarcinoma 2017 (CA 19.9 > 500IU/ml);
  • ECOG Performance Status ≤1;
  • adequate bone marrow function (GB ≥ 3500/mm3, neutrophils ≥1500/mm3, platelets ≥ 100000/mm3, Hb ≥10 g/dl), kidney function (serum creatinine < 1.5 mg/dL) and liverfunction (ALT and AST < 3 ULN and Serum total bilirubin ≤ 1.5 ULN);
  • Patient of child-bearing potential must agree to use two medically acceptable methodsof contraception (one for the patient and one for the partner) during the study andfor 4 months after the last study treatment intake for women and 6 months for men;
  • patients must have received at least 1 cycle (28 days) of the PAXG treatment for thedisease within the timeframe starting from January 1 2020 to December 31st 2020 ;
  • patient information and signed written informed consent.

Exclusion

Exclusion Criteria:

  • previous chemotherapy treatment for recurrent disease;
  • concurrent treatment with experimental drugs;
  • presence of symptomatic brain metastases;
  • heart failure, arrhythmia and/or acute myocardial infarction within 6 months prior tothe beginning of PAXG treatment;
  • women on pregnancy or lactation;
  • history of interstitial lung disease;
  • history of connective tissue diseases (systemic lupus erythematosus, systemicsclerosis, etc. ).

Study Design

Total Participants: 175
Study Start date:
July 08, 2020
Estimated Completion Date:
January 01, 2026

Study Description

Pancreatic Ductal Adenocarcinoma (PDAC) is one of the most lethal malignancies, with a 5-year overall survival (OS) rate for all stages combined lower than 10%, decreasing to 3% in advanced disease. Additionally, PDAC is expected to become the 2nd leading cause for cancer-related death by 2030. Chemotherapy still represents the only therapeutic option in most cases, since 70% of PDAC patients exhibit metastatic or locally advanced disease at diagnosis. Concerning metastatic PDAC patients, combination chemotherapy has resulted in improved survival compared with single-agent treatment. Based on promising phase I/II studies, the PAXG regimen (cisplatin, nab-paclitaxel, capecitabine and gemcitabine) has been recommended for first-line treatment of metastatic PDAC patients in the 2019 edition of Associazione Italiana Oncologia Medica (AIOM) guidelines. Also, this regimen was approved by the Agenzia Italiana del Farmaco (AIFA) as first therapy of borderline-resectable, locally advanced and metastatic PDAC patients with good performance status (ECOG 0-1) and age 18-75 years.

Description of the intervention (schedule of visits):

All PDAC patients who are treated with PAXG regimen as first-line/primary chemotherapy at the participating institutions from January 1st 2020 to December 31st 2020 according to inclusion and exclusion criteria will be included in the present study.

Power size calculation:

The sample size will be as large as possible with a competitive enrollment. All patients treated by the PAXG regimen during 2020 in the participating institutions will be included into the trial. The investigators hypothesize that at least 175 patients (60% metastatic and 40% non-metastatic) from about 30 Italian centers will be enrolled by the end of the year. Such a sample size, or a larger one, will allow to compute in both groups a 95% confident interval of the 1-year OS with at least 10% margin of error, assuming to observe a (target) 1-year OS of 60% for metastatic patients and of 80% for non-metastatic. The trial will be considered successful if the target 1-year OS will fall into the corresponding computed 95% CI.

Connect with a study center

  • IRCCS Centro di Riferimento Oncologico (CRO)

    Aviano,
    Italy

    Site Not Available

  • Istituto dei tumori Giovanni Paolo II

    Bari,
    Italy

    Site Not Available

  • AULSS 1 di Belluno

    Belluno,
    Italy

    Site Not Available

  • ASST Papa Giovanni XXIII

    Bergamo,
    Italy

    Site Not Available

  • Azienda Ospedaliera Policlinico Sant'Orsola-Malpighi

    Bologna,
    Italy

    Site Not Available

  • Azienda Ospedaliera AOU di Cagliari

    Cagliari,
    Italy

    Site Not Available

  • Ospedale di Carpi

    Carpi,
    Italy

    Site Not Available

  • USL Toscana Nord Ovest

    Carrara,
    Italy

    Site Not Available

  • Fondazione Istituto Giglio

    Cefalù,
    Italy

    Site Not Available

  • Ospedaliera Sant' Anna di Como Asst Lariana

    Como,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Ospedali Riuniti di Foggia

    Foggia,
    Italy

    Site Not Available

  • ASST Rhodense

    Garbagnate,
    Italy

    Site Not Available

  • Ospedale Moriggia Pelascini

    Gravedona,
    Italy

    Site Not Available

  • Ospedale Generale Provinciale di Macerata

    Macerata,
    Italy

    Site Not Available

  • Irccs Irst

    Meldola,
    Italy

    Site Not Available

  • ASST Melegnano e Della Martesana

    Melegnano,
    Italy

    Site Not Available

  • IRCCS San Raffaele Medical Oncology Unit

    Milan, 20132
    Italy

    Active - Recruiting

  • Istituto Oncologico Veneto IRCCS

    Padova,
    Italy

    Site Not Available

  • Ospedale Civico di Palermo

    Palermo,
    Italy

    Site Not Available

  • Azienda Ospedaliera di Parma

    Parma,
    Italy

    Site Not Available

  • Azienda Ospedaliera di Piacenza

    Piacenza,
    Italy

    Site Not Available

  • Giovanni Paolo II-Maria Paternò

    Ragusa,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi D'Aragona

    Salerno,
    Italy

    Site Not Available

  • AULSS 4 Veneto Orientale

    San Donà Di Piave,
    Italy

    Site Not Available

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo,
    Italy

    Site Not Available

  • Azienda Ospedaliera Ordine Mauriziano

    Torino,
    Italy

    Site Not Available

  • Presidio Ospedaliero Molinette

    Torino,
    Italy

    Site Not Available

  • Azienda Sanitaria Universitaria Integrata

    Udine,
    Italy

    Site Not Available

  • ASST Sette Laghi

    Varese,
    Italy

    Site Not Available

  • Ospedale San Bortolo Azienda ULSS8 Berica-Distretto Est

    Vicenza,
    Italy

    Site Not Available

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